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Class 2 Device Recall Microvent |
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Date Initiated by Firm |
January 13, 2004 |
Date Posted |
July 23, 2004 |
Recall Status1 |
Terminated 3 on September 01, 2004 |
Recall Number |
Z-1141-04 |
Recall Event ID |
28217 |
Product Classification |
Implant, Endosseous, Root-Form - Product Code DZE
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Product |
Microvent Implant Line |
Code Information |
MicroVent Implant Line Part # Description Lot Number Quantity MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0200515 100 MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0202923 100 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 014962 270 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 0200428 200 MV3H8 Impl, M-V II, HA, 3.7mm, 8mm 0202162 30 MV4H10 Impl, M-V II, HA, 4.7mm, 10mm 0200516 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 016646 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 0200427 100 MV4H8 Impl, M-V II, HA, 4.7mm, 8mm 0201180 35 |
Recalling Firm/ Manufacturer |
Zimmer Dental Inc 1900 Aston Ave Carlsbad CA 92008-7308
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Manufacturer Reason for Recall |
Sterility barrier compromised.
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FDA Determined Cause 2 |
Other |
Quantity in Commerce |
See Codes |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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